For many years, personal care companies have used a wide variety of ingredients that are now under scrutiny. Recently, Per- and Polyfluoroalkyl substances (PFAS) have received increased attention. Once intentionally added to products, several state laws ban or modify the total amount of these ingredients permitted in various products. Now, a new bill introduced in U.S. Congress late last year aims to follow suit.Continue Reading What’s In and What’s Out? Cosmetic Companies Face Ingredient Compliance Conundrum

On December 18, 2023, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, the electronic submission portal for facility registration and product listing required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and published a User Guide for the portal.[1] Cosmetics Direct contains user friendly data entry forms, performs initial validations, creates and saves the structured product labeling (SPL) submission, and submits the SPL to FDA.Continue Reading FDA Launches Cosmetics Direct and Issues Final Guidance on Facility Registration & Product Listings Required under MoCRA

On December 14, 2023, the FDA issued an update with further instructions on  serious adverse event reporting under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), which is enforceable starting December 29, 2023.Continue Reading FDA Provides Updated Instructions for Reporting Serious Adverse Events under MoCRA

Just over a month after the Food and Drug Administration (FDA) announced its intent to delay enforcement of facility registration and product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the Government Accountability Office (GAO) issued a report, “COSMETIC SAFETY: Better Planning Would Enhance FDA Efforts to Implement New Law,” with seven recommendations to strengthen FDA efforts to implement its new cosmetic oversight responsibilities.Continue Reading GAO Report Concludes that the FDA Needs to Strengthen its Efforts to Implement MoCRA

On October 13, 2023 The FDA announced that two of the requirements set forth in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)— facility registration and product listing—will be included as part of the Structured Product Labeling (SPL) framework. SPL is a document formatting standard adopted by FDA for exchanging product-related information. Continue Reading FDA Publishes SPL Guide for MoCRA Facility Registration and Product Listings

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) establishes a number of new requirements for the cosmetics industry. Among other things, facilities that manufacture and process cosmetics in the U.S. will need to be registered with the FDA, and companies that manufacture cosmetics will need to submit a list of all cosmetics (and their ingredients) to the FDA.Continue Reading FDA Seeks Comments on COSMETICS Direct for MoCRA Facility Registration and Product Listing

In December 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”)—the most significant expansion of the U.S. Food and Drug Administration’s authority to regulate cosmetics in nearly 85 years—was signed into law. Among other things, MoCRA gives the FDA authority to require facility registration and reporting of serious adverse events, impose certain record-keeping obligations, recall cosmetic products, and establish good manufacturing practices. With many of MoCRA’s provisions going into effect at the end of this year, cosmetics companies need to prepare to address these requirements and regulations, which may also have a considerable impact on the litigation landscape.

Crowell’s Product Risk Management team has written two publications to help cosmetics companies prepare for the big changes ahead.Continue Reading Modernization of Cosmetics Regulation Act (“MoCRA”) White Paper

On July 26, 2016, FDA issued an updated warning on beauty products, warning consumers to avoid certain “skin creams, beauty and antiseptic soaps, and lotions,” particularly those boasting “anti-aging” or “skin lightening” benefits, as potentially containing mercury.  While the dangers of mercury exposure are well-known, mercury’s ubiquity in certain beauty products is not.  Products that claim to “remove age spots, freckles, blemishes, and wrinkles,” including products targeting teenagers enduring acne, may contain mercury.  Checking the label can help—look out for words like “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or of course, “mercury”, but it’s not fool-proof.  As FDA points out, many of these beauty products are often made abroad and can be sold illegally in the U.S., without any labels. FDA continually monitors products like these, but is unable to catch all of them, especially due to their dubious channels of trade.  For those that FDA does catch, FDA sets up an import alert to prevent future influxes of such products.  Check here for all Consumer Updates from FDA.  Thus, retailers should do their due diligence to know what the chemical content is of the products they sell beyond the labels.

In its warning, FDA again mentioned one of its growing complaints levied against cosmetics – that the product may actually be an unapproved new drug under the law.
Continue Reading Beauty with a Side of Mercury?

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While a study hardly seems necessary to confirm it, an article published in the Journal of Global Fashion Marketing reports that of 289 cosmetics ads surveyed, only 18% could be viewed as generally trustworthy. While some may view this finding to be mere common sense, others – particularly plaintiffs’ counsel looking for potential class action claims – may view cosmetics as the next frontier after food labeling. After all, for an attorney with a “natural claim” lawsuit or similar complaint already drafted, the possibility of repurposing a ready-made legal formula may be highly appealing. Might cosmetics claims become the target of a new wave of false advertising litigation, akin to the “food wars”?Continue Reading Is Makeup About to Get Ugly? Plaintiffs’ Counsel May See the High Promises of Some Cosmetics Advertisements as a Source of Litigation

128021458Perusing the labels at your typical cosmetics counter or pharmacy aisle can feel akin to reading the menu of options for a smoothie bar.  “Antioxidants,” “Aloe,” “Vitamin C,” “Almond extract,” “natural fruit,” and “protein” all appear to be popular options.  When it comes to specifics, labels often vary from saying that an ingredient is contained